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Study protocol

Assessing the effectiveness and safety of liposomal paclitaxel in combination with cisplatin as first-line chemotherapy for patients with advanced NSCLC with regional lymph-node metastasis: study protocol for a randomized controlled trial (PLC-GC trial)

Abstract

Background

Lung cancer is still the leading cause of cancer-related mortality worldwide. Around
80 to 85% of lung cancers are non-small cell lung cancer (NSCLC). Regional lymphatic
metastasis is a frequent occurrence in NSCLC, and the extent of lymphatic dissemination
significantly determines the prognosis of patients with NSCLC. Hence, identification
of alternative treatments for these patients should be considered a priority. Liposomal
paclitaxel is a new formulation composed of paclitaxel and liposomes, with favorable
pharmacokinetic properties. In particular, it produces dramatically higher drug concentrations
in the lymph nodes than occurs with the current formulations of paclitaxel, thus we
believe that patients with NSCLC with regional lymphatic metastasis may benefit from
this new drug. Cisplatin-based doublet chemotherapy is recommended as the first-line
treatment for patients with advanced NSCLC. We have designed a trial to assess whether
first-line chemotherapy using liposomal paclitaxel combined with cisplatin (LP regimen)
is superior to gemcitabine combined with cisplatin (GP regimen) in efficacy (both
short-term and long-term efficacy) and safety (adverse events; AEs).

Method/Design

This is a prospective, open-label, controlled randomized clinical trial (RCT) to assess
the therapeutic effects and safety of liposomal paclitaxel. The study aims to enroll
126 patients, who will be randomly allocated to one of the two treatment groups (LP
and GP), with 63 patients in each group. Patients will receive four to six cycles
of the assigned chemotherapy, and primary outcome will be assessed every two cycles.
Patients will be recommended for surgery if the tumor becomes resectable. All participants
will be followed up for at least 12 months. The objective response rate (ORR), changes
in regional lymphatic metastasis (including number and size) and TNM (tumor, node,
metastasis) staging will be the primary outcome measures. Progression-free survival,
objective survival, median survival time, 1-year survival rate, toxicity, and time
to disease progression will be the secondary outcome measures.

Conclusions

A systematic search has indicated that this proposed study will be the first RCT to
evaluate whether liposomal paclitaxel plus cisplatin will have beneficial effects,
compared with gemcitabine plus cisplatin, on enhancing ORR, changing TNM staging,
improving long-term survival, and reducing the frequency of AEs for patients with
NSCLC with regional lymphatic metastasis.